News
FDA: Update on US Varenicline Supply
Manufacturers can now adequately supply the market with varenicline at or below the acceptable intake limit of 37ng per day.
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Safety Alerts and Recalls
Pfizer Expands Chantix Recall Due to Nitrosamine Impurity
To date, the Company has not received any reports of adverse events related to this recall.
News
Transcranial Magnetic Stimulation Device Cleared for Smoking Cessation
The outpatient procedure provides noninvasive magnetic stimulation to areas of the brain known to be associated with addiction.
Drugs in the Pipeline
FDA Panel Votes on OTC Nicotine Mouth Spray for Smoking Cessation
The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…
Generics News
First Generic Version of Chantix Now Available
Par's generic version of Chantix is currently the only available one in the US.
Drugs in the Pipeline
Novel Therapy for Alzheimer Disease Agitation Gets Breakthrough Designation
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
News, Safety Alerts and Recalls
Chantix Recalled, Distribution Halted Over Nitrosamine Impurity
Long-term use of a product containing N-nitroso-varenicline may be associated with an increased cancer risk based on data from closely related nitrosamine compounds.
Safety Alerts and Recalls
Pfizer Expands Recall to All Lots of Chantix Due to Nitrosamine Impurity
The recalled lots of Chantix were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from May 2019 to September 2021.
